US20110287403A1 - Graft Tensioning Device - Google Patents
Graft Tensioning Device Download PDFInfo
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- US20110287403A1 US20110287403A1 US12/784,701 US78470110A US2011287403A1 US 20110287403 A1 US20110287403 A1 US 20110287403A1 US 78470110 A US78470110 A US 78470110A US 2011287403 A1 US2011287403 A1 US 2011287403A1
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- United States
- Prior art keywords
- graft
- basin
- tensioner
- fluid
- tray
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/3662—Ligaments, tendons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/10—Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/40—Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24V—COLLECTION, PRODUCTION OR USE OF HEAT NOT OTHERWISE PROVIDED FOR
- F24V30/00—Apparatus or devices using heat produced by exothermal chemical reactions other than combustion
Definitions
- This application relates generally to medical devices, and specifically to medical devices used to prepare tissue grafts prior to and during joint stabilization procedures.
- Joint stabilization procedures including soft tissue replacement surgeries such as reconstruction or replacement of the anterior cruciate ligament, are performed to restore stability to an injured joint.
- a tissue graft such as a tendon graft or a bone-tendon-bone graft, is often used to replace failed tissues.
- Tissue grafts may be harvested from the patient (autograft), a cadaver (allograft), or even from a third-party living donor.
- Tissue grafts are generally harvested or prepared early in the surgical procedure and then preconditioned prior to implantation or reimplantation.
- the harvested graft often tendon strands, may be sutured together into a bundle in preparation for implantation.
- the graft is then typically preconditioned on a graft board, which involves holding the graft in tension to remove laxity from the tissue and, in the case of sutured grafts, to ensure proper alignment of the individual strands of tendon. It is understood that preconditioning the graft tends to minimize the influence of viscoelasticity after implantation.
- postoperative joint laxity is now known to be at least partially a result of the transition between the temperature and atmospheric conditions of the operating room and the temperature and atmospheric conditions of the body, it has been determined that maintaining grafts in conditions similar to those of the body during and/or throughout the procedure may reduce or eliminate the influence of a post implantation temperature increase on graft properties.
- the device comprises a basin capable of containing a fluid, a heating element disposed within or near the basin and capable of heating the fluid to an appropriate temperature, a tray disposed within the basin, and a graft holding fixture disposed atop the tray for maintaining a graft in tension, wherein the graft holding fixture and graft may be submersed within the fluid.
- the device further includes a base positioned in supportive relation to the basin, the heating element, the tray and the graft holding fixture.
- the device may include a shelf.
- the device may further include a cover.
- the device may further include a tube sizer.
- the device may be reusable, disposable, or partially disposable.
- FIG. 1 is an oblique plan view of a graft tensioning device, according to an embodiment of the invention
- FIG. 2 is a sectional view of the graft tensioning device, according to another embodiment of the invention.
- FIG. 3 is an oblique plan view of the graft tensioning device, according to yet another embodiment of the invention.
- FIG. 4 is a sectional view of the graft tensioning device, according to a further embodiment of the invention.
- FIG. 5 is a sectional view of the graft tensioning device, according to another embodiment of the invention.
- FIG. 6 is an oblique plan view of the graft tensioning device, according to a further embodiment of the invention.
- FIG. 7 is an end view of the graft hook, according to an embodiment of the invention.
- FIG. 8 is an oblique plan view of the graft tensioning device, according to another embodiment of the invention.
- FIG. 9 is a sectional view of the graft tensioning device, according to a further embodiment of the invention.
- FIG. 10 is a sectional view of the graft tensioning device, according to another embodiment of the invention.
- FIG. 11 is a sectional view of the graft tensioning device according to yet another embodiment of the invention.
- FIG. 12 is a sectional view of the graft tensioning device according to a further embodiment of the invention.
- FIG. 13 is a plan view of the graft tensioning device according to another embodiment of the invention.
- FIG. 14 is a sectional view of the graft tensioning device according to the embodiment set forth in FIG. 13 .
- the graft tensioning device 10 comprises a basin 30 , a heating element 40 disposed within or near the basin 30 , a graft holding fixture 60 and a tray 50 in supportive relation to the graft holding fixture 60 .
- the graft tensioning device 10 is designed to maintain a graft 94 in tension prior to, during and/or after a surgical procedure.
- the graft 94 may be a soft tissue graft, such as a tendon strand, or a graft that includes non-soft tissue, such as a bone-tendon-bone graft.
- the graft 94 may consist of a single strand or multiple strands as is known in the art.
- the basin 30 consists of one or more walls 33 and a floor 34 .
- the basin 30 is capable of containing a fluid 12 , including, but not limited to, a sterile saline or antibiotic rinse solution.
- the basin 30 may be any shape or configuration suitable for receiving the tray 50 and the fluid 12 .
- the basin 30 is rectangular in shape, however any shape is within the inventive concept.
- the one or more walls 33 of the basin 30 may consist of a shape necessary to account for placement of other components of the device.
- the basin 30 is preferably made of polyvinylchloride, HDPE, PETE, LDPE, polypropylene, or stainless steel, however any material is within the inventive concept.
- the basin 30 may further comprise a ledge 35 designed to receive the perimeter of the tray 50 and support the tray 50 above the floor 34 of the basin 30 .
- the heating element 40 may be any element capable of heating the fluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment.
- the heating element 40 may comprise electric power in watts appropriate to heat the fluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment.
- the heating element 40 may comprise chemical reactants capable of reacting to generate heat sufficient to heat the fluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment.
- the heating element 40 is preferably a submersible heating element, and may further comprise a temperature control device such as a thermocouple. As shown in FIGS.
- the heating element 40 is disposed within the basin 30 such that the heating element 40 may be used to warm the fluid 12 to an appropriate temperature.
- the heating element 40 is disposed outside the basin 30 such that the heating element 40 is capable of warming the fluid 12 within the basin 30 .
- the heating element 40 is capable of heating one liter of fluid to approximately 98 degrees in less than fifteen minutes.
- a 400 watt submersible heating element has been shown to heat approximately one liter of fluid from approximately 65 to approximately 99 degrees in approximately 12 minutes.
- the heating element 40 is further capable of maintaining a fluid at relatively consistent temperature. Consistency is maintained using a thermocouple, a microswitch or other temperature control device 95 .
- the power source for the heating element 40 may be alternating current or direct current depending on the configuration and intended method of using the device 10 .
- a preheated fluid 12 is used in lieu of heating element 40 .
- the tray 50 may be of any shape and size appropriate for being disposed within the basin 30 .
- the tray 50 is further designed to account for placement of the heating element 40 within the basin 30 .
- the shape of the tray 50 may be consistent with the shape of the basin 30 , as shown in FIG. 2 .
- the tray 50 may be smaller than the floor 34 of the basin 30 as shown in FIG. 3 .
- the tray 50 may comprise a cut away portion 52 A as shown in FIG. 1 .
- the tray 50 is preferably made of polyvinylchloride, HDPE, PET, or stainless steel, however any appropriate material is within the inventive concept.
- the tray 50 preferably comprises perforations 54 .
- the perforations 54 may be circular, as shown in FIG.
- the tray 50 may be of any shape, size and number such that fluid may pass through the tray 50 .
- the tray 50 is further designed to receive the graft holding fixture 60 as discussed in detail below.
- the tray 50 is suspended above the floor 34 of the basin 30 , such that the tray 50 does not rest against the floor 34 of the basin 30 , by one or more feet 55 (see FIGS. 4 and 9 ), a folded edge 56 (see FIG. 5 ), or the ledge 35 in the wall 33 of the basin 30 (see FIG. 2 ).
- the tray 50 rests against the floor 34 of the basin 30 or is secured to the floor 34 of the basin 30 .
- the tray 50 further includes an apparatus 53 to allow for placement of the tray 50 within the basin 30 and removal of the tray 50 from the basin 30 .
- the apparatus 53 may consist of one or more cutaway portions 52 B, as shown in FIG. 1 .
- the apparatus 53 may comprise one or more handles 51 secured to the tray 50 and extending above the surface of the fluid 12 .
- the device 10 does not include a tray 50 .
- the graft holding fixture 60 comprises a graft hook 70 and a graft tensioner 80 , positioned relative to one another such that a graft 94 may be secured therebetween during preconditioning.
- both components ( 70 and 80 ) of the graft holding fixture 60 are removably secured to the tray 50 .
- both components ( 70 and 80 ) of the graft holding fixture 60 are permanently secured to the tray 50 .
- one component ( 70 or 80 ) of the graft holding fixture 60 is permanently secured to the tray 50 while the other component ( 70 or 80 ) is removably secured to the tray 50 such that the distance between the components 70 and 80 is adjustable.
- the graft hook 70 and the graft tensioner 80 may be secured to the tray 50 using a peg board system wherein one or more pegs 62 located on the underside of both the graft hook 70 and the graft tensioner 80 are received by one or more perforations 54 of the tray 50 .
- a nut-like component 63 may be attached to each peg 62 after the peg 62 is disposed upon the tray 50 in order to secure the graft hook 70 and the graft tensioner 80 .
- the graft hook 70 and the graft tensioner 80 are mounted upon the rail 61 , the rail 61 being removably or permanently secured to the tray 50 by any suitable means.
- the graft hook 70 and the graft tensioner 80 comprise a recessed portion 64 for receiving the rail 61 and are moveable with respect to the rail 61 such that the distance between the graft hook 70 and the graft tensioner 80 is adjustable.
- One or more set screws, detents or stops may be used to secure the graft hook 70 and the graft tensioner 80 in a desired position along the rail 61 .
- the graft hook 70 and/or the graft tensioner 80 may be secured directly to the basin 30 .
- the graft hook 70 is capable of securing either end, both ends, or a folded portion of a graft 94 .
- the graft hook 70 includes a base 71 , a graft securing element 72 and an attachment mechanism 73 .
- the graft securing element 72 may comprise any means for securing a graft 94 , including, but not limited to, one or more hooks, clips, pins, posts, loops or clamps.
- the attachment mechanism 73 may be the peg 62 affixed to the base 71 , the recessed portion 64 for receiving the rail 61 , or any other suitable means for permanently or removably attaching the graft hook 70 to the tray 50 or the basin 30 .
- the graft hook 70 includes a weighted bar 101 and the graft securing element 72 .
- the graft tensioner 80 is capable of securing either end, both ends or a folded portion of a graft 94 .
- the graft tensioner 80 includes a base 81 , a graft securing element 82 , a tensioning component 83 , a latching mechanism 84 , and an attachment mechanism 85 .
- the graft securing element 82 may comprise any means for securing a graft, including, but not limited to, one or more hooks, clips, pins, posts, loops or clamps.
- the tensioning component 83 may be any means for applying tension to the graft 94 .
- the tensioning component 83 is a spring 96 or other linear elastic component.
- the spring 96 may be a weak spring, a strong spring, or anything in between.
- the elastic properties of the spring 96 should be chosen according to the particular application for which it is intended. For example, a weak spring 96 may prevent slack as the graft 94 relaxes, but may not add significant additional tension to the system. This type of spring 96 may be appropriate for pediatric surgery or a surgery in which a single bundle graft 94 is used.
- a strong spring 96 may be used to apply significant tension to a graft 94 , perhaps during an anterior cruciate ligament reconstruction in which a multi-bundled graft 94 is used.
- the spring 96 is color coded according to its elastic properties, such that a medical professional may easily select the spring 96 that he or she believes is appropriate for a particular application.
- the latching mechanism 84 is a mechanism for temporarily maintaining the spring 96 in an extended, relaxed or compressed position.
- the latching mechanism 84 may be used, for example, to maintain the spring 83 in an extended position such that a graft 94 may be readily secured to the graft tensioner 80 by the graft securing element 82 .
- the attachment mechanism 85 may be the peg 62 affixed to the base 81 , a recessed portion 64 for receiving the rail 61 , or any other suitable means for permanently or removably attaching the graft tensioner 80 to the tray 50 or the basin 30 .
- the graft tensioner 80 includes the graft securing element 82 and the tensioning component 83 .
- the tensioning component 83 is a gravity based system comprising a string or cable 97 and a weight 98 .
- the weight 98 is attached to the cable 97 .
- the cable 97 is attached to the graft securing element 82 and routed over the wall 33 of the basin 30 .
- the graft tensioner 80 may further include a pulley 99 for routing the string or cable 97 over or through the wall 33 of the basin 30 .
- the graft 94 may be positioned vertically, for example, by securing the graft hook 70 to the wall 33 of the basin 30 .
- the appropriate weight 98 is secured to the graft 94 via the graft securing element 82 , and thereby suspended from the graft 94 .
- the graft tensioning device 10 further comprises a base 20 .
- the basin 30 and other components of device 10 are disposed within the base 20 .
- the base 20 consists of one or more walls 21 and a floor 22 .
- the base 20 may be any shape or size capable of containing the basin 30 and the fluid 12 disposed within the basin 30 .
- the base 20 is preferably of metal or plastic, however any suitable material is within the inventive concept.
- the base 20 and the basin 30 are two separate and disjoinable component pieces.
- the base 20 and the basin 30 are one continuous piece of manufacture.
- the heating element 40 is disposed either within the base 20 and within the basin 30 , or within the base 20 and exterior to the basin 30 .
- the graft tensioning device 10 further comprises a shelf 90 for supporting the tray 50 outside of the fluid 12 .
- the shelf 90 may be any surface for supporting the tray 50 above the surface of the fluid 12 .
- the shelf 90 may comprise a flat projection extending inward or outward from one side of the base 20 and/or basin 30 .
- the shelf 90 may comprise a lip or ledge for securing the tray 50 above the surface of the fluid 12 .
- the shelf 90 is permanent.
- the shelf 90 is removable or collapsible.
- the shelf 90 may support the tray 50 while a medical professional prepares the graft 94 and secures the graft 94 to the graft tensioning fixture 60 .
- the shelf 90 may further be used to support the tray 50 following preconditioning and before implantation.
- the device 10 further comprises one or more tube sizers 91 , as known in the art, for placing around the graft 94 to prevent, control and/or monitor the expansion of the graft 94 during preconditioning.
- the tube sizer 91 comprises perforation to allow for penetration of the fluid 12 .
- the tube sizer 91 is preferably made of plastic or metal, however any material is within the inventive concept.
- Various embodiments of the device further include a cover 92 to assist in maintaining the temperature and/or sterility of the system, among other things.
- the device 10 is permanent or reusable.
- each component part is of a material designed to withstand conditions including moist heat by steam autoclaving, dry heat, ethylene oxide gas and gamma radiation for the purpose of sterilization.
- the device 10 is partially disposable and partially reusable.
- the base 20 and the heating element 40 may be permanent or reusable, while the basin 30 , the tray 50 and the graft holding fixture 60 may be disposable.
- the device 10 is disposable.
- the graft tensioning device 10 is suitable for use within an operating room. While in use, the basin 30 contains an appropriate fluid 12 .
- the graft hook 70 and the graft tensioner 80 are secured to the tray 50 by any suitable means. According to one embodiment, the tray 50 may rest on shelf 90 during the preparation of the device and the harvesting of the graft 94 .
- a medical professional selects the linear elastic element 96 appropriate for a particular application.
- the linear elastic element 96 is secured to the graft tensioner 80 .
- the linear elastic element 96 may be placed in an extended position and temporarily maintained in the extended position by the latching mechanism 84 .
- the graft 94 is secured to the graft hook 70 , by graft securing element 72 , and the graft tensioner 80 , by graft securing element 82 .
- the latching mechanism 84 may be released, thereby applying tension to the graft 94 .
- the medical professional selects the weight 98 appropriate for a given application. The weight 98 is secured to the graft 94 by either the cable 97 and/or the graft securing element 82 .
- a tuber sizer 91 may be positioned around the graft prior to securing the graft to the graft hook 70 and the graft tensioner 80 .
- the medical professional may use apparatus 53 to lower the tray 50 into the basin 30 containing fluid 12 .
- the time, temperature and tension necessary to condition the graft is determined by an appropriate medical professional.
- the tray 50 Prior to implantation of the graft 94 , the tray 50 is removed from basin 30 using apparatus 53 .
Abstract
Description
- This application relates generally to medical devices, and specifically to medical devices used to prepare tissue grafts prior to and during joint stabilization procedures.
- Joint stabilization procedures, including soft tissue replacement surgeries such as reconstruction or replacement of the anterior cruciate ligament, are performed to restore stability to an injured joint. During such surgeries a tissue graft, such as a tendon graft or a bone-tendon-bone graft, is often used to replace failed tissues. Tissue grafts may be harvested from the patient (autograft), a cadaver (allograft), or even from a third-party living donor.
- Tissue grafts are generally harvested or prepared early in the surgical procedure and then preconditioned prior to implantation or reimplantation. The harvested graft, often tendon strands, may be sutured together into a bundle in preparation for implantation. The graft is then typically preconditioned on a graft board, which involves holding the graft in tension to remove laxity from the tissue and, in the case of sutured grafts, to ensure proper alignment of the individual strands of tendon. It is understood that preconditioning the graft tends to minimize the influence of viscoelasticity after implantation.
- Even when prepared under tension, it is common for grafts to continue to lengthen and stretch after implantation. This relaxation of the graft contributes to post-operative joint laxity resulting in instability of the joint.
- Recent research, as published in articles such as Viscoelasticity and Temperature Variations Decrease Tension and Stiffness of Hamstring Tendon Grafts Following Anterior Cruciate Ligament Reconstruction, T
HE JOURNAL OF BONE AND JOINT SURGERY, 2006, p. 1071, Dr. William J. Ciccone II, Derek R Bratton, David M. Weinstein, and John J. Elias, has shown that the tension and the stiffness of a graft may significantly decrease due to both stress relaxation and an increase in temperature. This new information has led doctors and scientists to believe that the graft tension and stiffness achieved immediately following reconstruction is not maintained postoperatively due to the change in conditions between the operating room and the inside of the human body. Because postoperative joint laxity is now known to be at least partially a result of the transition between the temperature and atmospheric conditions of the operating room and the temperature and atmospheric conditions of the body, it has been determined that maintaining grafts in conditions similar to those of the body during and/or throughout the procedure may reduce or eliminate the influence of a post implantation temperature increase on graft properties. - In view of the foregoing, there is a need to provide a graft tensioning device that allows a graft to be maintained at conditions similar to those found within the human body during the preconditioning process. The present invention addresses one or more of these needs.
- According to one embodiment, the device comprises a basin capable of containing a fluid, a heating element disposed within or near the basin and capable of heating the fluid to an appropriate temperature, a tray disposed within the basin, and a graft holding fixture disposed atop the tray for maintaining a graft in tension, wherein the graft holding fixture and graft may be submersed within the fluid.
- According to another embodiment, the device further includes a base positioned in supportive relation to the basin, the heating element, the tray and the graft holding fixture.
- In various embodiments, the device may include a shelf.
- In various embodiments, the device may further include a cover.
- In various embodiments, the device may further include a tube sizer.
- In various embodiments, the device may be reusable, disposable, or partially disposable.
- Other independent features and advantages of the graft tensioning device will become apparent from the following Detailed Description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
-
FIG. 1 is an oblique plan view of a graft tensioning device, according to an embodiment of the invention; -
FIG. 2 is a sectional view of the graft tensioning device, according to another embodiment of the invention; -
FIG. 3 is an oblique plan view of the graft tensioning device, according to yet another embodiment of the invention; -
FIG. 4 is a sectional view of the graft tensioning device, according to a further embodiment of the invention; -
FIG. 5 is a sectional view of the graft tensioning device, according to another embodiment of the invention; -
FIG. 6 is an oblique plan view of the graft tensioning device, according to a further embodiment of the invention; -
FIG. 7 is an end view of the graft hook, according to an embodiment of the invention; -
FIG. 8 is an oblique plan view of the graft tensioning device, according to another embodiment of the invention; -
FIG. 9 is a sectional view of the graft tensioning device, according to a further embodiment of the invention; -
FIG. 10 is a sectional view of the graft tensioning device, according to another embodiment of the invention; -
FIG. 11 is a sectional view of the graft tensioning device according to yet another embodiment of the invention; -
FIG. 12 is a sectional view of the graft tensioning device according to a further embodiment of the invention; -
FIG. 13 is a plan view of the graft tensioning device according to another embodiment of the invention; and -
FIG. 14 is a sectional view of the graft tensioning device according to the embodiment set forth inFIG. 13 . - The following Detailed Description of the invention is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any theory presented in the preceding Background or Summary or the following Detailed Description. Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
- According to one embodiment, as illustrated in
FIG. 1 , thegraft tensioning device 10 comprises abasin 30, aheating element 40 disposed within or near thebasin 30, agraft holding fixture 60 and atray 50 in supportive relation to thegraft holding fixture 60. Thegraft tensioning device 10 is designed to maintain agraft 94 in tension prior to, during and/or after a surgical procedure. Thegraft 94 may be a soft tissue graft, such as a tendon strand, or a graft that includes non-soft tissue, such as a bone-tendon-bone graft. Thegraft 94 may consist of a single strand or multiple strands as is known in the art. - The
basin 30 consists of one ormore walls 33 and afloor 34. Thebasin 30 is capable of containing afluid 12, including, but not limited to, a sterile saline or antibiotic rinse solution. Thebasin 30 may be any shape or configuration suitable for receiving thetray 50 and thefluid 12. According to the embodiment ofFIGS. 1 , 3, 6 and 8, thebasin 30 is rectangular in shape, however any shape is within the inventive concept. As shown inFIG. 13 , the one ormore walls 33 of thebasin 30 may consist of a shape necessary to account for placement of other components of the device. Thebasin 30 is preferably made of polyvinylchloride, HDPE, PETE, LDPE, polypropylene, or stainless steel, however any material is within the inventive concept. As shown inFIG. 2 , thebasin 30 may further comprise aledge 35 designed to receive the perimeter of thetray 50 and support thetray 50 above thefloor 34 of thebasin 30. - The
heating element 40 may be any element capable of heating thefluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment. For example, theheating element 40 may comprise electric power in watts appropriate to heat thefluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment. Alternatively, theheating element 40 may comprise chemical reactants capable of reacting to generate heat sufficient to heat thefluid 12 from approximately room temperature to approximately at or above body temperature in a time that is realistic in a surgical environment. Theheating element 40 is preferably a submersible heating element, and may further comprise a temperature control device such as a thermocouple. As shown inFIGS. 1 , 2, 8 and 9, theheating element 40 is disposed within thebasin 30 such that theheating element 40 may be used to warm thefluid 12 to an appropriate temperature. Alternatively, theheating element 40 is disposed outside thebasin 30 such that theheating element 40 is capable of warming thefluid 12 within thebasin 30. According to one embodiment, theheating element 40 is capable of heating one liter of fluid to approximately 98 degrees in less than fifteen minutes. By way of example only, a 400 watt submersible heating element has been shown to heat approximately one liter of fluid from approximately 65 to approximately 99 degrees in approximately 12 minutes. Theheating element 40 is further capable of maintaining a fluid at relatively consistent temperature. Consistency is maintained using a thermocouple, a microswitch or othertemperature control device 95. The power source for theheating element 40 may be alternating current or direct current depending on the configuration and intended method of using thedevice 10. According to yet another embodiment, apreheated fluid 12 is used in lieu ofheating element 40. - The
tray 50 may be of any shape and size appropriate for being disposed within thebasin 30. Thetray 50 is further designed to account for placement of theheating element 40 within thebasin 30. For example, the shape of thetray 50 may be consistent with the shape of thebasin 30, as shown inFIG. 2 . Alternatively, thetray 50 may be smaller than thefloor 34 of thebasin 30 as shown inFIG. 3 . Further, thetray 50 may comprise a cut awayportion 52A as shown inFIG. 1 . Thetray 50 is preferably made of polyvinylchloride, HDPE, PET, or stainless steel, however any appropriate material is within the inventive concept. Thetray 50 preferably comprisesperforations 54. Theperforations 54 may be circular, as shown inFIG. 1 , or may be of any shape, size and number such that fluid may pass through thetray 50. Thetray 50 is further designed to receive thegraft holding fixture 60 as discussed in detail below. According to one embodiment thetray 50 is suspended above thefloor 34 of thebasin 30, such that thetray 50 does not rest against thefloor 34 of thebasin 30, by one or more feet 55 (seeFIGS. 4 and 9 ), a folded edge 56 (seeFIG. 5 ), or theledge 35 in thewall 33 of the basin 30 (seeFIG. 2 ). According to other embodiments, as shown inFIG. 3 , thetray 50 rests against thefloor 34 of thebasin 30 or is secured to thefloor 34 of thebasin 30. According to one embodiment, thetray 50 further includes anapparatus 53 to allow for placement of thetray 50 within thebasin 30 and removal of thetray 50 from thebasin 30. For example, theapparatus 53 may consist of one or morecutaway portions 52B, as shown inFIG. 1 . Alternatively, as illustrated inFIGS. 4 and 5 , theapparatus 53 may comprise one ormore handles 51 secured to thetray 50 and extending above the surface of the fluid 12. According to yet other embodiments, as shown inFIGS. 11 and 12 , thedevice 10 does not include atray 50. - The
graft holding fixture 60 comprises agraft hook 70 and agraft tensioner 80, positioned relative to one another such that agraft 94 may be secured therebetween during preconditioning. - According to one embodiment, both components (70 and 80) of the
graft holding fixture 60 are removably secured to thetray 50. According to another embodiment, both components (70 and 80) of thegraft holding fixture 60 are permanently secured to thetray 50. According to yet another embodiment, one component (70 or 80) of thegraft holding fixture 60 is permanently secured to thetray 50 while the other component (70 or 80) is removably secured to thetray 50 such that the distance between thecomponents graft hook 70 and thegraft tensioner 80 may be secured to thetray 50 using a peg board system wherein one ormore pegs 62 located on the underside of both thegraft hook 70 and thegraft tensioner 80 are received by one ormore perforations 54 of thetray 50. As shown inFIG. 2 , a nut-like component 63 may be attached to eachpeg 62 after thepeg 62 is disposed upon thetray 50 in order to secure thegraft hook 70 and thegraft tensioner 80. According to another embodiment, and as shown inFIGS. 6 and 7 , thegraft hook 70 and thegraft tensioner 80 are mounted upon therail 61, therail 61 being removably or permanently secured to thetray 50 by any suitable means. Thegraft hook 70 and thegraft tensioner 80 comprise a recessedportion 64 for receiving therail 61 and are moveable with respect to therail 61 such that the distance between thegraft hook 70 and thegraft tensioner 80 is adjustable. One or more set screws, detents or stops may be used to secure thegraft hook 70 and thegraft tensioner 80 in a desired position along therail 61. According to yet other embodiments, thegraft hook 70 and/or thegraft tensioner 80 may be secured directly to thebasin 30. - The
graft hook 70, the first element of thegraft holding fixture 60, is capable of securing either end, both ends, or a folded portion of agraft 94. According to one embodiment, set forth inFIG. 2 , thegraft hook 70 includes abase 71, agraft securing element 72 and anattachment mechanism 73. Thegraft securing element 72 may comprise any means for securing agraft 94, including, but not limited to, one or more hooks, clips, pins, posts, loops or clamps. Theattachment mechanism 73 may be thepeg 62 affixed to thebase 71, the recessedportion 64 for receiving therail 61, or any other suitable means for permanently or removably attaching thegraft hook 70 to thetray 50 or thebasin 30. Alternatively, as set forth inFIG. 13 , thegraft hook 70 includes aweighted bar 101 and thegraft securing element 72. - The
graft tensioner 80, the second element of thegraft holding fixture 60, is capable of securing either end, both ends or a folded portion of agraft 94. According to one embodiment, as set forth inFIG. 2 , thegraft tensioner 80 includes abase 81, agraft securing element 82, atensioning component 83, alatching mechanism 84, and anattachment mechanism 85. Thegraft securing element 82 may comprise any means for securing a graft, including, but not limited to, one or more hooks, clips, pins, posts, loops or clamps. Thetensioning component 83 may be any means for applying tension to thegraft 94. According to one embodiment, as shown, for example, inFIGS. 1 and 2 , thetensioning component 83 is a spring 96 or other linear elastic component. According to that embodiment, the spring 96 may be a weak spring, a strong spring, or anything in between. The elastic properties of the spring 96 should be chosen according to the particular application for which it is intended. For example, a weak spring 96 may prevent slack as thegraft 94 relaxes, but may not add significant additional tension to the system. This type of spring 96 may be appropriate for pediatric surgery or a surgery in which asingle bundle graft 94 is used. A strong spring 96 may be used to apply significant tension to agraft 94, perhaps during an anterior cruciate ligament reconstruction in which amulti-bundled graft 94 is used. According to one embodiment, the spring 96 is color coded according to its elastic properties, such that a medical professional may easily select the spring 96 that he or she believes is appropriate for a particular application. Thelatching mechanism 84 is a mechanism for temporarily maintaining the spring 96 in an extended, relaxed or compressed position. Thelatching mechanism 84 may be used, for example, to maintain thespring 83 in an extended position such that agraft 94 may be readily secured to thegraft tensioner 80 by thegraft securing element 82. Once thegraft 94 is secured to both thegraft hook 70 and thegraft tensioner 80, thelatching mechanism 84 may be released, allowing thespring 83 to retract, thereby applying tension to thegraft 94. Theattachment mechanism 85 may be thepeg 62 affixed to thebase 81, a recessedportion 64 for receiving therail 61, or any other suitable means for permanently or removably attaching thegraft tensioner 80 to thetray 50 or thebasin 30. - According to another embodiment, as shown in
FIGS. 10 , 11, 12, 13 and 14, thegraft tensioner 80 includes thegraft securing element 82 and thetensioning component 83. According to the embodiment set forth inFIGS. 10 and 11 , thetensioning component 83 is a gravity based system comprising a string orcable 97 and aweight 98. Theweight 98 is attached to thecable 97. Thecable 97 is attached to thegraft securing element 82 and routed over thewall 33 of thebasin 30. According to another embodiment, thegraft tensioner 80 may further include apulley 99 for routing the string orcable 97 over or through thewall 33 of thebasin 30. According to yet another embodiment, shown inFIG. 12 , thegraft 94 may be positioned vertically, for example, by securing thegraft hook 70 to thewall 33 of thebasin 30. According to this embodiment, theappropriate weight 98 is secured to thegraft 94 via thegraft securing element 82, and thereby suspended from thegraft 94. - According to yet another embodiment, the
graft tensioning device 10 further comprises abase 20. According to this embodiment, shown inFIGS. 8 and 9 , thebasin 30 and other components ofdevice 10 are disposed within thebase 20. Thebase 20 consists of one ormore walls 21 and afloor 22. The base 20 may be any shape or size capable of containing thebasin 30 and the fluid 12 disposed within thebasin 30. Thebase 20 is preferably of metal or plastic, however any suitable material is within the inventive concept. According to one embodiment, thebase 20 and thebasin 30 are two separate and disjoinable component pieces. According to yet another embodiment, thebase 20 and thebasin 30 are one continuous piece of manufacture. According to either of these embodiments, theheating element 40 is disposed either within thebase 20 and within thebasin 30, or within thebase 20 and exterior to thebasin 30. - According to another embodiment, and as shown in
FIG. 5 , thegraft tensioning device 10 further comprises ashelf 90 for supporting thetray 50 outside of the fluid 12. Theshelf 90 may be any surface for supporting thetray 50 above the surface of the fluid 12. For example, theshelf 90 may comprise a flat projection extending inward or outward from one side of thebase 20 and/orbasin 30. Further, theshelf 90 may comprise a lip or ledge for securing thetray 50 above the surface of the fluid 12. According to one embodiment theshelf 90 is permanent. According to other embodiments, theshelf 90 is removable or collapsible. Theshelf 90 may support thetray 50 while a medical professional prepares thegraft 94 and secures thegraft 94 to thegraft tensioning fixture 60. Theshelf 90 may further be used to support thetray 50 following preconditioning and before implantation. - According to another embodiment, and as shown in
FIGS. 8 and 9 , thedevice 10 further comprises one ormore tube sizers 91, as known in the art, for placing around thegraft 94 to prevent, control and/or monitor the expansion of thegraft 94 during preconditioning. According to yet another embodiment, thetube sizer 91 comprises perforation to allow for penetration of the fluid 12. Thetube sizer 91 is preferably made of plastic or metal, however any material is within the inventive concept. - Various embodiments of the device further include a
cover 92 to assist in maintaining the temperature and/or sterility of the system, among other things. - According to one embodiment, the
device 10 is permanent or reusable. For that embodiment, each component part is of a material designed to withstand conditions including moist heat by steam autoclaving, dry heat, ethylene oxide gas and gamma radiation for the purpose of sterilization. According to other embodiments, thedevice 10 is partially disposable and partially reusable. For example, thebase 20 and theheating element 40 may be permanent or reusable, while thebasin 30, thetray 50 and thegraft holding fixture 60 may be disposable. According to yet another embodiment, thedevice 10 is disposable. - The
graft tensioning device 10 is suitable for use within an operating room. While in use, thebasin 30 contains anappropriate fluid 12. Thegraft hook 70 and thegraft tensioner 80 are secured to thetray 50 by any suitable means. According to one embodiment, thetray 50 may rest onshelf 90 during the preparation of the device and the harvesting of thegraft 94. According to one embodiment, a medical professional selects the linear elastic element 96 appropriate for a particular application. The linear elastic element 96 is secured to thegraft tensioner 80. The linear elastic element 96 may be placed in an extended position and temporarily maintained in the extended position by thelatching mechanism 84. Once thegraft 94 is harvested from a patient or otherwise obtained, thegraft 94 is secured to thegraft hook 70, bygraft securing element 72, and thegraft tensioner 80, bygraft securing element 82. Once the graft is appropriately secured, thelatching mechanism 84 may be released, thereby applying tension to thegraft 94. According to another embodiment, the medical professional selects theweight 98 appropriate for a given application. Theweight 98 is secured to thegraft 94 by either thecable 97 and/or thegraft securing element 82. According to any of the foregoing embodiments, atuber sizer 91 may be positioned around the graft prior to securing the graft to thegraft hook 70 and thegraft tensioner 80. Once thegraft 94 is affixed to thegraft holding fixture 60, the medical professional may useapparatus 53 to lower thetray 50 into thebasin 30 containingfluid 12. The time, temperature and tension necessary to condition the graft is determined by an appropriate medical professional. Prior to implantation of thegraft 94, thetray 50 is removed frombasin 30 usingapparatus 53. - While the invention has been described with reference to a preferred embodiment or embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to a particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.
Claims (34)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/784,701 US20110287403A1 (en) | 2010-05-21 | 2010-05-21 | Graft Tensioning Device |
US15/209,099 US20160317710A1 (en) | 2010-05-21 | 2016-07-13 | Graft tensioning methods |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/784,701 US20110287403A1 (en) | 2010-05-21 | 2010-05-21 | Graft Tensioning Device |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US15/209,099 Continuation US20160317710A1 (en) | 2010-05-21 | 2016-07-13 | Graft tensioning methods |
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US20110287403A1 true US20110287403A1 (en) | 2011-11-24 |
Family
ID=44972780
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US12/784,701 Abandoned US20110287403A1 (en) | 2010-05-21 | 2010-05-21 | Graft Tensioning Device |
US15/209,099 Abandoned US20160317710A1 (en) | 2010-05-21 | 2016-07-13 | Graft tensioning methods |
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US15/209,099 Abandoned US20160317710A1 (en) | 2010-05-21 | 2016-07-13 | Graft tensioning methods |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11458010B2 (en) | 2018-04-16 | 2022-10-04 | United Health Services Hospitals, Inc. | Medical holding system and method for facilitating the preparation of implantable elements |
US11464620B2 (en) | 2018-04-16 | 2022-10-11 | United Health Services Hospitals, Inc. | Pivot-based medical holding system and method |
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US20020040240A1 (en) * | 2000-09-28 | 2002-04-04 | Richard Wolf Gmbh | Device for conditioning a ligament to be implanted |
US20030229394A1 (en) * | 2002-06-06 | 2003-12-11 | Ogle Matthew F. | Processed tissue for medical device formation |
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US20060293752A1 (en) * | 2005-06-27 | 2006-12-28 | Missoum Moumene | Intervertebral disc prosthesis and associated methods |
US20080243248A1 (en) * | 2007-03-30 | 2008-10-02 | Biomet Sports Medicine, Inc. | In situ graft preparation for knee ligament reconstruction |
US20100206226A1 (en) * | 2007-07-25 | 2010-08-19 | Yasuhiko Kitayama | Tissue piece treating apparatus |
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- 2010-05-21 US US12/784,701 patent/US20110287403A1/en not_active Abandoned
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US5279612A (en) * | 1989-06-09 | 1994-01-18 | Medtronic, Inc. | Dynamic fixation of porcine aortic valves |
US5415651A (en) * | 1993-02-18 | 1995-05-16 | Arthrex, Inc. | Work station for preparing a bone-tendon-bone core graft |
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US5922393A (en) * | 1996-08-06 | 1999-07-13 | Jayaraman; Swaminathan | Microporous covered stents and method of coating |
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US11458010B2 (en) | 2018-04-16 | 2022-10-04 | United Health Services Hospitals, Inc. | Medical holding system and method for facilitating the preparation of implantable elements |
US11464620B2 (en) | 2018-04-16 | 2022-10-11 | United Health Services Hospitals, Inc. | Pivot-based medical holding system and method |
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